Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000217404
Ethics application status
Approved
Date submitted
16/04/2007
Date registered
20/04/2007
Date last updated
21/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren’s Contracture
Scientific title
A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren’s Contracture
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dupuytren's contracture 1745 0
Condition category
Condition code
Musculoskeletal 1836 1836 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.58mg of Clostridial collagenase (AA4500) will be injected directly into the Dupuytren's cord. 30 days after the first injection, if no response is seen or if the previously injected cord responds and the patient has an additional Dupuytren's cord to be treated, a second dose of AA4500 will be injected directly either into the initially injected Dupuytren's cord or into the second Dupuytren's cord as appropriate. A maximum of 5 injections will be given, 30 days apart, but if they only have 1 Dupuytren's cord to treat and respond to the first injection they will not proceed with any further injections and will enter the follow-up phase of the study.
Follow-up phase:
Subjects will be reviewed at 3, 6 and 9 months after the first injection. At these visits the study objectives will be reviewed.
Intervention code [1] 1705 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2572 0
To evaluate the safety of up to 5 injections of AA4500 0.58 mg (maximum 3 injections per joint) in reducing the degree of contracture (flexion deformity) in multiple joints of subjects with Dupuytren’s contracture.

Assessment of safety: adverse events; vital signs; grip strength of treated hand
Timepoint [1] 2572 0
At baseline, immediately before each injection and day 1, day 7 and day 30 after each injection of AA4500. Plus during the follow-up phase at 3 months, 6 months and 9 months after the initial injection of AA4500.
Primary outcome [2] 2573 0
To evaluate the safety of up to 5 injections of AA4500 0.58 mg (maximum 3 injections per joint) in reducing the degree of contracture (flexion deformity) in multiple joints of subjects with Dupuytren’s contracture.

Assessment of safety: clinical laboratory tests
Timepoint [2] 2573 0
At baseline and during the follow-up phase at 3 months, 6 months and 9 months after the initial injection of AA4500.
Primary outcome [3] 2574 0
To evaluate the safety of up to 5 injections of AA4500 0.58 mg (maximum 3 injections per joint) in reducing the degree of contracture (flexion deformity) in multiple joints of subjects with Dupuytren’s contracture.

Assessment of safety: level of antibodies against collagenase formed
Timepoint [3] 2574 0
Immediately before each injection and day 30 after each injection of AA4500. Plus during the follow-up phase at 3 months, 6 months and 9 months after the initial injection of AA4500
Primary outcome [4] 2575 0
To evaluate the efficacy of up to 5 injections of AA4500 0.58 mg (maximum 3 injections per joint) in reducing the degree of contracture (flexion deformity) in multiple joints of subjects with Dupuytren’s contracture.

Assessment of efficacy: The change in the degree of contracture of the joint affected by the treated Dupuytren's cord, measured by digital goniometry.
Timepoint [4] 2575 0
At baseline, immediately before each injection and day 1, day 7 and day 30 after each injection of AA4500. Plus during the follow-up phase at 3 months, 6 months and 9 months after the initial injection of AA4500.
Secondary outcome [1] 4431 0
None
Timepoint [1] 4431 0

Eligibility
Key inclusion criteria
1. Subjects must have a diagnosis of Dupuytren’s contracture with a fixed-flexion (ie, = 20º but = 80º for PIP joint; = 20º but = 100º for MP joint) deformity of the finger that is caused by a palpable cord 2. Subject must have a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. 3. Subject is judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile. 4. Subject voluntarily signs and dates an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). 5. Female subjects of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (ie, no menses for at least 1 year). A pregnancy test will be performed prior to enrollment in the study. A pregnancy test will be performed prior to enrollment in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female subjects who are nursing or pregnant, or plan to become pregnant during the treatment phase.2. Subject has received an investigational drug within 30 days prior to the first dose of study drug.3. Subject has received treatment for Dupuytren’s contracture within 90 days of enrollment on the joint selected for the initial injection of AA4500. Treatment for Dupuytren’s contracture includes surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.4. Subject has a known allergy to collagenase or any other excipient of AA4500.5. Subject has received doxycycline or doxycycline derivative during the 14 days prior to the first dose of study drug.6. Subject has received any collagenase treatments within 30 days.7. Subject is receiving anticoagulant medication or has received anticoagulant medication (except for aspirin = 150 mg daily) within 7 days before the first injection.8. Subject has a known recent history of stroke, bleeding, or other medical condition which in the investigator’s opinion would make the subject unsuitable for enrollment in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 514 0
United Kingdom
State/province [1] 514 0

Funding & Sponsors
Funding source category [1] 1986 0
Commercial sector/Industry
Name [1] 1986 0
Auxilium Pharmaceuticals, Inc.
Country [1] 1986 0
Primary sponsor type
Commercial sector/Industry
Name
Auxilium Pharmaceuticals, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 1798 0
Commercial sector/Industry
Name [1] 1798 0
Novotech (Australia) Pty Ltd
Address [1] 1798 0
Country [1] 1798 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3690 0
Emeritus Research
Ethics committee address [1] 3690 0
Melbourne, VIC
Ethics committee country [1] 3690 0
Australia
Date submitted for ethics approval [1] 3690 0
Approval date [1] 3690 0
22/01/2007
Ethics approval number [1] 3690 0
04-11-12-06
Ethics committee name [2] 3691 0
Peninsula Clinical Research Centre
Ethics committee address [2] 3691 0
Brisbane, QLD
Ethics committee country [2] 3691 0
Australia
Date submitted for ethics approval [2] 3691 0
Approval date [2] 3691 0
06/12/2006
Ethics approval number [2] 3691 0
06/DEC/03

Summary
Brief summary
The purpose of the study is to test whether injections of AA4500 are safe and will dissolve the cord of tissue causing the bending of the finger(s) due to Dupuytren's disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27808 0
Address 27808 0
Country 27808 0
Phone 27808 0
Fax 27808 0
Email 27808 0
Contact person for public queries
Name 10894 0
Kerin Singleton
Address 10894 0
Novotech (Australia) Pty Ltd
Level 3
19 Harris Street
Pyrmont NSW 2009
Country 10894 0
Australia
Phone 10894 0
+61 2 95189600
Fax 10894 0
+61 2 95189390
Email 10894 0
kerin.singleton@novotech-cro.com
Contact person for scientific queries
Name 1822 0
Nigel Jones
Address 1822 0
Auxilium UK Limited
Orchard Lea
Winkfield Lane
Windsor
Berks
SL4 4RU
Country 1822 0
United Kingdom
Phone 1822 0
+44 (0)1443 421707
Fax 1822 0
+44 (0)1443 433044
Email 1822 0
nigelj@auxilium.com

No information has been provided regarding IPD availability


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No Supporting Document Provided


Results publications and other study-related documents

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